Sepraspray™ Laparoscopic Myomectomy Study

Genzyme, a Sanofi Company41 enrolled

Overview

The purpose of this research study is to obtain preliminary data of the safety and effectiveness of Sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion prevention barrier after laparoscopic myomectomy versus no adhesion barrier.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Laparoscopic Myomectomy

Interventions

SeprasprayDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and SLL. Exclusion Criteria: * Pregnant/lactating women. * The patient has a history of hypersensitivity to exogenous carboxymethylcellulose products and/or hyaluronic acid. * The patient's procedure resulted in entry of the endometrial cavity, or entry of the bowel including appendectomy.

Locations (3)

Unnamed facility

Naperville, Illinois, United States

Unnamed facility

Philadelphia, Pennsylvania, United States

Unnamed facility

Austin, Texas, United States

Outcomes

Primary Outcomes

The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage.

Time frame: 30 Days post surgery

Efficacy endpoints are on adhesion formation and will include the success the success criterion for the individual patients as either anterior or posterior uterus free of dense adhesions.

Time frame: Until end of study

Data from ClinicalTrials.gov

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